Occlusion device and methods of using the same

ABSTRACT

An occlusion device for occluding a body vessel and methods of using the device are disclosed.

BACKGROUND

The present invention generally relates to embolization or occlusiondevices for the human and animal body.

An embolization or occlusion device can be placed within the lumen orinterior space of an organ or physiological conduit including arteries,veins, vessels, the bilary tree, the urinary tract, the alimentarytract, the tracheobronchial tree, the genitourinary system, and thecerebral aqueduct. Occlusion devices are used for a number of differentpurposes, all with the common feature that it is desired to limit orstop the free flow of fluid or blood in an area of the body.

One example of an endovascular field of application for occlusiondevices for percutaneous, transluminal insertion using minimallyinvasive techniques, is occlusion of an aneurism to prevent rupture ofthe vessel wall with resulting bleeding. Other applications includeocclusion or treatment of varicose veins, occlusion of arteriovenousmalformations (AVM), blocking of the blood flow to a tumor, and/orclosure of traumatically conditioned blood flows caused by wounds,bodily injuries or gastrointestinal bleeding.

Occlusion devices can be used in many different places in the vascularsystem and in vessels of differing sizes and geometries. Therefore, manydifferent occlusion devices have been designed with various basicpredetermined shapes and of varying sizes. Conventionally, thepredetermined shape of the occlusion device is made so that the body ofthe device has a diameter of the same size or slightly larger than therelevant vessel lumen, so that the body of the device exerts an abutmentpressure against the vessel wall. When it is desirable to quicklyocclude a blood vessel, an inflatable balloon may be temporarily used.Another example of a more permanent occlusion device includesembolization coils, which may promote blood clots or tissue growth overa period of time, thereby occluding the body cavity and/or vessel lumen.Occlusion devices having other shapes and structures may also be used asnecessary or desired, including but not limited to barrels, disks, wiresand/or fibers.

To deliver an occlusion device, a delivery assembly including aguidewire and a catheter may be placed transluminally in the vascularsystem having its distal catheter end at the site of placement. When theocclusion device leaves the distal end of the catheter, it seeks toassume a predetermined shape within the vessel or alternatively, it canbe mechanically expanded within the vessel. If the size and shape of thedevice are deemed suitable for the vessel geometry at the site ofplacement, the occlusion device is disconnected from the components ofthe delivery assembly and the assembly removed from the vasculature.

Disclosed herein is an improved occlusion device for occluding a bodylumen and/or vessel. Also disclosed is a delivery assembly and methodsfor placing and retrieving an occlusion device within a body vessel.

SUMMARY

In one example, an occlusion device for occluding a body lumen isdisclosed. The occlusion device comprises a proximal end, a distal endspaced from the proximal end along a longitudinal axis, and an occludingmember disposed between the proximal end and distal end. The occludingmember has a radially-outwardly expanded configuration and a contractedconfiguration. At least one biasing member is disposed within theoccluding member and extends between the proximal and distal ends alonga longitudinal axis, the biasing member having a contractedconfiguration and an extended configuration. When the occlusion memberis in the expanded configuration the biasing member is in the contractedposition and when the occlusion member is in the contractedconfiguration the biasing member is in the extended position.

Another example of an occlusion device for occluding a body vessel isalso disclosed. The occlusion device comprises a proximal end, a distalend spaced from the proximal end along a longitudinal axis and anoccluding member disposed between the proximal end and distal end. Theoccluding member has a radially-outwardly expanded configuration and acontracted configuration. A first biasing member is disposed within theoccluding member having a first end adjoined to the proximal end of thedevice, and a second biasing member is disposed within the occludingmember having a first end adjoined to the distal end of the device. Thesecond biasing member is configured to releasably engage the firstbiasing member.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial section of a body vessel including one example of anocclusion device in a radially expanded deployed configuration therein.

FIG. 2 is a partial section of the occlusion device of FIG. 1 in acollapsed delivery configuration within an outer sheath and a distalportion of one example of a delivery assembly.

FIG. 3 is a partial section of another example of an occlusion device ina collapsed delivery configuration within an outer sheath and a distalportion of one example of a delivery assembly.

FIG. 4 is a partial section of a body vessel including another exampleof an occlusion device in a radially expanded deployed configurationtherein.

FIG. 5 is a side view of one example of a delivery and retrievalassembly for use with an occlusion device.

FIG. 6 is an exploded view of the delivery and retrieval assembly ofFIG. 5.

FIG. 7 illustrates one example of the distal end of the a deliverydevice engaged with the occlusion device within a delivery sheath.

FIG. 8 illustrates one example of a delivery sheath partially withdrawnand the distal end of a delivery device disengaged from the occlusiondevice.

DETAILED DESCRIPTION

Throughout this specification the terms “proximal” and “proximally” areused to refer to a position or direction towards the patient's heart andthe terms “distal” and “distally” are used for a position or directionaway the patient's heart when describing an occlusion device. In thearterial system, downstream refers to the direction further from theheart, while upstream refers to the direction closer to the heart. Theterms proximal and distal, when used herein in relation to instrumentsused in the procedure, such as a delivery assembly, delivery device,catheter, guide wire and the like, refer to directions closer to andfarther away from the operator performing the procedure. Thus, a distalend of a delivery catheter or guide wire would be farther away from theoperator, while the proximal end of a delivery catheter or guide wirewould be closer to the operator.

Referring now to FIG. 1, a first embodiment of an occlusion device isdesignated at 10. The occlusion device 10 includes a first or proximalhub 12 extending from a proximal end 14 to a distal end 16 and along alongitudinal axis 18 with a tubular wall 20 optionally defining a lumen22. A proximal end 26 of an occluding member 24 is attached to theproximal hub 12 and extends distally therefrom for attachment at itsdistal end 28 to a second or distal hub 30. Distal hub 30 has a proximalend 32 and a distal end 34, with a tubular wall 36 optionally defining asecond lumen 38. The occluding member 24 may define an interior volumeor space 40. Preferably, at least a portion of member 24 forms anocclusive barrier when deployed within a body lumen and/or vessel 42.

By way of example, occlusion member 24 may extend between the distal end16 of the first (proximal) hub 12 and a proximal end 32 of the second(distal) hub 30. A middle portion 44 of the occluding member 24 extendsradially away from the longitudinal axis 18 when the device 10 is in anopen configuration to form a wider diameter portion 46. In one example,the wider diameter portion 46 of the occlusion member 24 is generallycentered or formed within a middle section 44 of occluding member 24,but alternatively, the wider diameter portion 46 may be off-center, suchthat it is located closer to one hub or the other as needed, depending,for example, on the particular use of the device 10 or the patient'sunique anatomy. Preferably, the wider diameter portion 46 extendsradially outwardly for a wide enough distance so that at least a portionof the occlusion member 24 is substantially adjacent to and/or abuts thevessel wall when the device 10 is deployed within the body vessel 42 asshown in FIG. 1 and FIG. 4. Preferably, at least part of the occlusionmember 24, such as wider diameter portion 46, extends outwardly from thelongitudinal axis 18 and achieves sufficient radial force against atleast a portion of the vessel wall to hold and/or secure the device 10in place so that risk of dislodgment and/or migration of the device 10is substantially reduced or otherwise eliminated. The radially outwardexpansion of the device upon delivery and deployment is described infurther detail below.

As further illustrated in FIGS. 1 and 4, the occlusion member 24 maytaper radially inwardly from the wider diameter portion 46 to a morenarrow diameter portions 48, 50 at each of the respective proximal anddistal ends 26, 28. The more narrow diameter portions 48, 50 may beattached to one or both of the respective hubs 12, 30 by variousattachment means, including welding, adhesive, glue, friction fit orsimilar attachment members (e.g., screws, threads) or alternatively,member 24 may be integrally formed with one or both of the hubs 12, 30.As illustrated in FIG. 1, the proximal and/or distal ends 26, 28 of theocclusion member 24 may be crimped down or otherwise contracted radiallyinwardly so that they can be held by, inserted into or otherwiseretained within the respective proximal and distal hubs 12, 30.

Optionally, the occlusion member 24 and/or one or both of hubs 12, 30may include anchoring members (not shown). The anchoring members mayhave any appropriate shape to keep the device 10 from moving ormigrating within the body vessel 42. The anchoring members may include aplurality of barbs. Other examples of the anchoring members may includehooks, roughened surfaces or other similar structures that may engagethe vessel wall and serve to prevent migration or dislodgement of thedevice 10 after deployment in the vessel 42.

One or both of the proximal and/or distal hubs 12, 30 may be formed atleast partially from a radiopaque material, including, but not limitedto stainless steel and/or gold, and/or radiopaque polymers or alloys orinclude one or more radiopaque markers to enhance visibility andplacement during delivery, such as with a fluoroscope. In onenon-limiting example, one or both of the hubs 12, 30 may be formed froma stainless steel cannula having a size in the range of about 0.300 mmto about 1.100 mm and preferably about 0.899 mm. As shown in FIGS. 1-4,one or both of the hubs 12, 30 and preferably the proximal hub 12 mayinclude a rounded or smooth atraumatic tip 52 placed thereon. In oneexample, the atraumatic tip 52 is formed in a bullet-nose shape, but mayalso include other domed, smooth or rounded shapes. The atraumatic tip52 may either be removably secured to the proximal hub 12 to aid in theplacement and delivery of the device 10 in a desired location within avessel or body lumen, after which time the tip 52 may be removed fromthe device 10 during and/or after deployment. Alternatively, theatraumatic tip 52 may be permanently secured to the proximal hub 12 suchthat it remains secured to the device 10 when it is deployed within avessel 42, or, in yet another alternative, the proximal hub 12 itselfmay be atraumatically shaped, smooth and/or rounded. An atraumaticallyshaped hub 12 and/or atraumatic tip 52 may facilitate the ease ofdelivery and placement of the device 10 in tortuous anatomy while alsoreducing or eliminating vessel damage or injury.

The occluding member 24 may be a variety of structures including, butnot limited to, one or more wires, coils, fabrics, fibers, flexiblearcuate members, cages, screens, disks, walls and the like and may beconstructed or formed from a single material or, alternatively, may beformed from a variety or combination of materials. In one example, atleast a portion of occlusion member 24 may be formed of any suitablematerial that may be expanded, such as by mechanical expansion. In otherexamples, at least a portion of the occlusion member may be formed fromany suitable material that will result in a self-opening orself-expanding device 10, such as shape memory material. Shape memorymaterial that is heated (or cooled) above (or below) a transitiontemperature causes the material to undergo a phase transformation suchthat the material returns to its “remembered” state. Thus, when thedevice 10 is deployed in a body vessel 42 having a particulartemperature the device 10 will transform to the remembered (expanded)state within the vessel 42. To remove the device 10, it may be cooled(or, alternatively heated) to transform the material to a more malleablestate, such that the device 10 can be more easily collapsed and pulledinto a lumen of a catheter (re-sheathed) for removal. One shape memoryalloy suitable for the present invention is Ni—Ti, also known asnitinol.

As shown in FIG. 1 and FIG. 4, occlusion member 24 is preferably formedof a woven mesh constructed of nitinol wire and a polyester fiber(polyethylene terephthalate commonly abbreviated PET, PETE) or referredto by the trade name Dacron®. The nitinol and polyester fiber mesh maybe woven in any suitable combination or ratio, and in one example, thematerials may be woven together in a ratio of 1:1 to form a mesh. Thepolyester fibers may act as a thrombogenic agent upon delivery andnesting of the device in a vessel 42 or body lumen. In an alternativeembodiment, the occlusion member 24 may also be at least partiallyconstructed of materials such as, but not limited to, nylon, rayon,biocompatible polyurethanes, polytetrafluoroethylene (known as PTFE orunder the trade name Teflon®), and mixtures thereof.

In addition to a woven mesh of nitinol and a polyester fiber, theocclusion member 24 may also include or incorporate yet another materialsuch as a coating, or, as part of the woven mesh, a connective tissuematerial including extracellular matrix (ECM) comprised of smallintestinal submucosa (SIS). In one particular embodiment, the SIS may beused to temporarily adhere at least part of the occlusion member 24 tothe walls of the body vessel 42 in which the device 10 is deployed.Since it may be desirable to only temporarily occlude the body vessel42, when the device 10 is deployed in the body vessel, host cells of thewall may adhere to a portion of the device 10 but will notdifferentiate, allowing for later retrieval of the device 10 from thebody vessel 42. However, in other applications where more permanentocclusion is desired, the device 10 may remain in place and the hostcells of the wall may differentiate into the occlusion member 24,eventually replacing the SIS with the host cells of the body vessel 42.

When introduced into a body vessel 42, the device 10 may be orientedsuch that the proximal hub 12 is directed into a direction of blood flowas indicated by the arrow 54. Alternatively, the device may beintroduced into the vessel in the opposite orientation such that thedistal hub is oriented into a direction of blood flow, so in otherwords, the device may not be directionally dependent and can beintroduced in a direction or orientation as necessary or desireddepending on the procedure and/or location in the body. As previouslymentioned, the device 10, and in particular at least a portion ofocclusion member 24, is configured to prevent blood, emboli and otherfluids from passing, thereby occluding the body vessel 42. As previouslymentioned, the occlusion member 24 extends radially around thelongitudinal axis 18 thus forming an interior volume or space 40. In oneexample, the interior space 40 may also include one or more additionalstructures (not shown) that form an additional barrier to fluid (such asblood). This may include, for example, one or more disk-like structuresthat lie substantially perpendicular to the longitudinal axis 18,springs, coils and/or a plurality fibers extending radially with respectto the axis 18. Any one or more of these additional occluding structuresmay be wholly contained within the volume 40, and in other examples, maylie outside the volume 40.

As best shown in FIGS. 2 and 3, the occlusion member 24 preferablycollapses into a closed or radially inwardly contracted “delivery”configuration extending substantially along the longitudinal axis 18during delivery of the device 10. For example, during delivery, thedevice 10 is preferably disposed within an outer delivery sheath 56 of adelivery assembly 100 which retains the device 10 in its radiallycontracted state during delivery. The outer delivery sheath 56 has atubular body 58 extending from a proximal part 62 to a distal part 60.An inner member or catheter 64 is disposed within a sheath lumen 66 andis configured for axial movement relative to the outer sheath 56. Theinner catheter 64 may be any type of elongate pushing member including,for example, a rod, stylet, or the like. The device 10 is removablycoupled to a distal portion 68 of the inner catheter 64 and isdeployable through the distal end 60 of the outer delivery sheath 56 bymeans of the relative axial movement of the inner catheter 64. Inanother example, the device 10 is not coupled to the inner catheter 64but is merely pushed by the inner catheter 64 through the sheath 56 to adesired delivery location within a patient's body.

The device 10 may be removably coupled to the inner catheter 64 invarious ways. For example, the distal portion 68 of the inner catheter64 may be configured to engage at least one of the proximal and/ordistal hubs 12, 30. In one example, the distal portion 68 may include aflexible threading coil for engaging the hub. Examples of a threadingcoil are disclosed in U.S. Pat. No. 5,725,534; U.S. Pat. No. 6,458,137and/or U.S. Pat. No. 8,308,752; which are herein incorporated byreference. The device 10 may also be removeably coupled to the deliveryassembly by other attachment mechanisms, including friction fit,fasteners or coupling appendages. As best shown in FIGS. 2 and 3, theproximal and/or distal ends and/or hubs 12, 30 may include a couplingmechanism 70. As illustrated, the coupling mechanism 70 is formed ondistal hub 30 and may be any complimentary feature appropriate forengaging the inner catheter 64. The coupling mechanism 70 formed on thehub 30 may be a female opening, such as lumen 38 that may be threaded,an aperture, a slot, a recess, indentation, cut-out or the like, oralternatively, it may be a male structure, such as a flange, finger orprojection that may, if desired, be threaded. The inner catheter 64preferably includes a complimentary structure configured to engage withthe coupling mechanism 70 on the hub 30. As FIG. 2 and FIG. 3illustrates, the hub 30 includes a female opening 72, which ispreferably formed as a recess or cut-out, that is shaped to receive acorrespondingly shaped male projection 74 formed on the distal end 68 ofthe delivery catheter 64. As shown there, the male projection 74 can begenerally described as having a “lollipop” shape which is received by asimilarly shaped recess 72 formed in the hub 30 for capturing thelollipop 74. Of course, other corresponding shapes, including but notlimited to square, rectangle, diamond or other shapes, forms orengageable structures formed on the hub 30 and on the catheter 64 mayalso be suitable which allow for the device 10 to be releasably securedto the delivery assembly 100.

As shown in more detail in FIGS. 7 and 8, the distal end 68 of thedelivery catheter 64 comprises two “lollipop” shaped projections 74extending therefrom. The two projections 74 may be diametrically opposedstructures that are received by two correspondingly shaped recesses 72formed in hub 30. The delivery catheter 64 and projections 74 may beformed from the same material or alternatively, the projections 74 maybe formed of a material different from that of the catheter 64. In oneexample, the projections 74 are formed at least partially from ashape-memory alloy such as Nitinol. Thus, in a natural, relaxed state,the projections 74 flare radially outwardly at the distal-most end 75.Thus, when sheath 56 is retracted to expose the distal end 68 of thedelivery catheter 64 as illustrated in FIG. 8, the projections 74 becomeradially outwardly flared such that the diameter formed between distalmost ends 75 of projections 74 is greater than the diameter of thedistal end 68 of delivery catheter 64. However, when the distal end 68of the delivery catheter 64 is sheathed such that the sheath 56 coversthe projections 74 as shown in FIGS. 3 and 7, the projections are pushedradially inwardly and urged into and “captured” by the correspondinglyshaped recesses 72 formed in the hub. As illustrated in FIG. 7, theprojections 74 remain captured within recesses 72, as the diameterbetween the distal-most ends 75 of the projections 74 is approximatelythe same as the diameter of the distal end 68 of the delivery catheter64 when contained by the sheath. In use, retraction of the sheath 56 andsubsequent outward flaring of projections 74 results in the projections74 being separated from the recesses 72 as FIGS. 4 and 8 show. Thisallows the occlusion device 10 to be uncoupled from the deliverycatheter 64 and deployed at a desired location within a vessel. Ifrecapture, repositioning and/or removal of the device 10 is desired,re-sheathing of the distal end 68 of the delivery catheter 64 and of thedevice 10 (by pushing the sheath distally) urges the projections 74radially inwardly and back into the recesses 72. With the projections 74again captured by the recesses 72 and held in position within the sheath56, the device 10 can be repositioned or retracted from the vessel 42.

As mentioned above, at least part of the occlusion member 24, such aswider diameter portion 46, extends radially outwardly from thelongitudinal axis 18 when deployed such that it achieves sufficientradial force against at least a portion of the vessel wall 42. Suchradial outward expansion of the device 10 upon deployment may beachieved in several ways. First, in one example, one or more resilientinner central elongate member(s) 76 extends between the proximal anddistal hubs 12, 30 as shown in FIGS. 1 and 2. In the example shown, onecentral elongate member 76 may include a coiled member or spring thatextends substantially along the longitudinal axis 18 and may optionallydefine a third lumen (not shown) between the first and second lumens 22and 38 of the first and second hubs 12 and 30. A proximal end 78 of thespring 76 is secured to the proximal hub 12 and a distal end 80 of thespring 76 is secured to the distal hub 30. The proximal and distal ends78, 80 of the spring 76 may be secured or adjoined to the respectivehubs 12, 30 by various suitable attachment mechanisms, includingwelding, adhesives, friction fit, threading and/or other attachmentmembers. The spring 76 is preferably biased in a contracted condition,such that when in a relaxed state (e.g., upon deployment of device 10when the delivery sheath 56 is retracted and removed), the ends 78, 80of the spring 76 contract towards each other, thus pulling therespective proximal and distal hubs 12, 30 towards each other. As such,the woven mesh of the occlusion member 24 extends radially outwardly ata location 44 that is generally centered between the respective hubs 12,30 to form a substantially elliptical, ovoidal or egg-shape asillustrated in FIG. 1. In other words, the device 10 is generallyself-expanding in that the central elongate member 76 contracts in itsnatural state when unsheathed, thus, promoting expansion of theocclusion member 24. The contraction of the central elongate member 76may alone provide a self-expanding device 10. However, as previouslymentioned, occlusion member 24 may also be constructed of a materialhaving self-expanding properties (e.g. a woven mesh including nitinol,for example) which may radially self-expand in its natural relaxed state(e.g., when the delivery sheath 56 is retracted and removed). Thus, theself-expanding properties of central elongate member 76 alone and/or incombination with an occlusion member 24 that may also includeself-expanding properties, facilitates radial self-expansion of thedevice 10 within a vessel.

The central elongate member 76 is also preferably longitudinallyextensible such that it can be lengthened or stretched to facilitate aradially constricted delivery configuration of the device 10 as shown inFIG. 2. As such, the central elongate member 76 may be made from anappropriate resilient elastic material, including elastic polymer,stainless steel coil, a spring or any other appropriate flexiblematerial that allows for longitudinal extension and contraction. Whenthe device 10 is sheathed, the respective hubs 12 and 30 are extendedaway from each other in substantially opposing directions, thuslongitudinally extending the central elongate member 76. As a result,the occlusion member 24 becomes radially inwardly contracted into a moreslender delivery profile within the sheath 56. Withdrawal of the sheath56 allows for the device 10 to radially outwardly self-expand within thevessel as shown in FIG. 1 and described in detail herein.

In alternative example, radial outward expansion of the occlusion device10 may be achieved by providing two separate inner central elongatemembers 82, 84 coupled to each of the respective hubs 12, 30 as shown inFIGS. 3 and 4. The two central elongate members 82, 84 may be in theform of springs or coils, or alternatively, two correspondingly shapedthreaded members, one of which is configured to receive the other in athreadedly engaging manner. The two elongate members 82, 84 preferablyextend from each of the respective hubs 12, 30 towards each other to apoint where their respective terminating ends are adjacent, and/or abutas shown in FIG. 3, and are capable of otherwise engaging each other asshown in FIG. 4. One of the elongate members, such as the distal member84 illustrated in FIG. 4, may be rotated relative to the other elongatemember 82. Such rotation may be achieved by rotation of the deliverycatheter 64 by the user, which, in turn, causes rotation of the distalelongate member 84. Rotation of the distal elongate member 84 causes thetwo elongate members 82, 84 to engage each other (such as by oneelongate member threadedly engaging the other elongate member) asillustrated in FIG. 4 which, in turn, pulls the respective hubs 12, 30towards each other along the longitudinal axis. As the hubs 12, 30 arepulled towards each other, the woven mesh of the occlusion member 24becomes extended radially outwardly at a location generally between therespective hubs 12, 30 to form a substantially elliptical, ovoidal oregg-shape as illustrated in FIG. 4. Similarly, rotation of distalelongate member 84 (such as by rotation of the catheter 64 in theopposite direction) causes the elongate members 82, 84 to unthread orotherwise disengage, thus moving the respective hubs 12, 30longitudinally away from each other, such that the occlusion member 24may be returned to a radially-inwardly constricted deliveryconfiguration, as illustrated in FIG. 3 and, if necessary or desired,the device 10 may be recaptured or resheathed for adjustment and/orrelocation of the device 10.

FIGS. 5 and 6 depict a delivery assembly 100 for introducing andretrieving an occlusion device 10 for occluding a body vessel 42. Asshown, the delivery assembly 100 preferably includes an introducersheath 102 that may be constructed from various flexible biocompatiblematerials such as polytetrafluoroethylene (PTFE), for percutaneouslyintroducing an outer delivery sheath 56 into a body vessel 42. Ofcourse, any other suitable material for the introducer sheath 102, orouter delivery sheath 56 may be used. The introducer sheath 102 may haveany suitable size, for example, between about three-french totwelve-french, depending on the particular use and location of deliveryand deployment. The introducer sheath 102 serves to allow the outerdelivery sheath 56 and an inner member or catheter 64 to bepercutaneously inserted to a desired location in the body cavity and/orvessel 42. The introducer sheath 102 receives the outer delivery sheath56 and provides stability to the outer delivery sheath 56 as the outerdelivery sheath 56 is advanced through the introducer sheath 102 to anocclusion area in the vasculature. As shown in FIGS. 5 and 6 the outerdelivery sheath 56 has a hub 104 at its proximal end sized andconfigured to receive the inner catheter 64 and occlusion device 10 tobe advanced therethrough. The size of the outer delivery sheath 56 maybe based on the size of the body vessel 42 in which it percutaneouslyinserts, and the size of the device 10.

As shown, the assembly 100 may also include a wire guide 106 configuredto be percutaneously inserted within the vasculature to guide the outerdelivery sheath 56 to the occlusion area. The wire guide 106 providesthe outer delivery sheath 56 with a path to follow as it is advancedwithin the body vessel 42. The size of the wire guide 106 may be basedon the inside diameter of the outer delivery sheath 56 and the diameterof the target body vessel 42. In one non-limiting example, a wire havinga size of about 0.018 inches to about 0.038 inches may be used.

When a distal end 108 of the outer delivery sheath 56 is at the desiredlocation in the body vessel 42, the wire guide 106 is removed and theocclusion device 10, having a distal segment, end and/or hub 30contacting, coupled to or otherwise releasably engaged with a distalportion 68 of the inner catheter 64, is inserted into the outer deliverysheath 56. The inner catheter 64 is advanced through the outer deliverysheath 56 for deployment of the device 10 through the distal end 108 toocclude the body vessel 42 during treatment of, for example, ananeurism. Preferably, the distal portion 68 of the inner catheter 64includes a coupling mechanism as previously described which, in onenon-limiting example, comprises a male coupling or protrusion 74generally in the shape of a lollipop for releasably engaging orotherwise coupling to a correspondingly female-shaped opening, aperture,cut-out, slot and/or recess 72 formed in distal hub 30 of the device 10.Alternatively, the occlusion device 10 may be removably attached to thedistal portion 68 of the inner catheter 64 in other known ways aspreviously mentioned, or in yet another example, the inner catheter 64may not be attached to the device 10, but instead, the inner catheter 64may simply be used to push the device 10 through delivery sheath 56 toits desired deployment location.

Following removal of the wire guide 106, the device 10 and innercatheter 64 are coaxially advanced through the outer delivery sheath 56in order to position the device 10 to occlude the body vessel 42. Thedevice 10 is guided through the outer delivery sheath 56 by the innercatheter 64, preferably from the hub 104, and exits from the distal end108 of the outer delivery sheath 56 at a location within the vasculaturewhere occlusion is desired. Likewise, the device 10 may be retrievedand/or repositioned by positioning the distal end 108 of the outerdelivery sheath 56 adjacent the deployed device 10 in the vasculature.The inner catheter 64 is advanced through the outer delivery sheath 56until the distal portion 68 protrudes from the distal end 108 of theouter delivery sheath 56. The distal portion 68 is coupled to a distalend or hub 30 of the device 10, such as by female recess 72 of couplingmechanism 70 capturing male protrusion 74, after which the innercatheter 64 is retracted proximally, drawing the device 10 into theouter delivery sheath 56 for repositioning and/or removal.

The occlusion device 10 and methods of use described herein provideseasy, efficient, safe and dependable occlusion of a vessel and/or bodylumen with improved stasis time and minimal risk of migration of thedevice 10. Advantageously, occlusion device 10 may be provided in avariety of sizes, shapes, lengths and combinations thereof, thusproviding an immediately deliverable design for achieving occlusiveproperties for multiple uses and varying locations of placement, servingunique patient anatomies and shortening occlusion and stasis times. Itis understood that the delivery assembly described above is merely oneexample of an assembly that may be used to deliver and deploy theocclusion device 10 in a body vessel. Of course, other apparatus,assemblies and systems may be used to deploy any embodiment of theocclusion device in a vessel, organ or body lumen as necessary ordesired.

Throughout this specification, unless the context requires otherwise,the words “comprise” and “include” and variations such as “comprising”and “including” will be understood to imply the inclusion of an item orgroup of items, but not the exclusion of any other item or group items.

While various embodiments of the invention have been described, it willbe apparent to those of ordinary skill in the art that many moreembodiments and implementations are possible within the scope of theinvention. Furthermore, although various indications have been given asto the scope of this invention, the invention is not limited to any oneof these but may reside in two or more of these combined together.Accordingly, the invention is not to be restricted except in light ofthe attached claims and their equivalents.

1. An occlusion device for occluding a body lumen comprising: a proximalend, a distal end spaced from the proximal end along a longitudinalaxis, an occluding member disposed between the proximal end and distalend, the occluding member moveable between a radially-outwardly expandedconfiguration and a contracted configuration, at least one biasingmember attached to and disposed within the occluding member andextending between the proximal and distal ends along a longitudinalaxis, the biasing member having a contracted configuration and anextended configuration such that when the biasing member is in thecontracted position the occlusion member is moved to the expandedconfiguration and when the biasing member is in the extended positionthe occlusion member is moved to the contracted configuration.
 2. Theocclusion device of claim 1 wherein the proximal end of the occlusiondevice comprises a proximal hub and wherein the distal end of theocclusion device comprises a distal hub.
 3. The occlusion device ofclaim 2 wherein the at least one biasing member is attached to theproximal and distal hubs.
 4. The occlusion device of claim 1 wherein thebiasing member is biased in the contracted configuration.
 5. Theocclusion device of claim 1 wherein the biasing member is a helicalcoil.
 6. The occlusion device of claim 1 wherein at least a portion ofthe occluding member comprises a woven mesh.
 7. The occlusion device ofclaim 6 wherein at least a portion of the woven mesh forms an occlusivebarrier that extends radially around the longitudinal axis.
 8. Theocclusion device of claim 1 wherein the longitudinal axis comprises amidpoint located approximately halfway between the proximal and distalends of the device and wherein the occlusion member extends radiallyoutwardly away from the longitudinal axis to define a largest diameterat the midpoint when the occlusion member is in an expandedconfiguration.
 9. The occlusion device of claim 6 wherein the woven meshcomprises a self-expanding material and a polyester fiber.
 10. Theocclusion device of claim 9 wherein the self-expanding material andpolyester fiber are woven in a ratio of at least one of 1:1; 1:2; 1:3;1:4; 2:1; 3:1 and 4:1.
 11. The occlusion device of claim 1 wherein atleast one of the proximal and distal ends comprises a radiopaquematerial.
 12. The occlusion device of claim 1 wherein at least one ofthe proximal and distal ends is configured for releasable attachment toa delivery device.
 13. The occlusion device of claim 1 wherein at leastone of the proximal and distal ends comprises an atraumatic tip.
 14. Anocclusion device for occluding a body vessel comprising: a proximal end,a distal end spaced from the proximal end along a longitudinal axis, anoccluding member disposed between the proximal end and distal end, theoccluding member moveable between a radially-outwardly expandedconfiguration and a contracted configuration, a first biasing memberdisposed within the occluding member and having a first end adjoined tothe proximal end of the device, a second biasing member disposed withinthe occluding member and having a first end adjoined to the distal endof the device, the second biasing member configured to engage the firstbiasing member.
 15. The occlusion device of claim 14 wherein whenproximal and distal ends are moved towards each other along thelongitudinal axis, the occlusion member is moveable to the expandedconfiguration, and when proximal and distal ends are moved away fromeach other along the longitudinal axis, the occlusion member is moveableto the contracted configuration.
 16. The occlusion device of claim 14wherein at least one of the first and second biasing members isrotatable with respect to the other biasing member.
 17. The occlusiondevice of claim 14 wherein at least one of the first and second biasingmembers is a helical coil.
 18. The occlusion device of claim 14 whereinat least one of the first and second biasing members is threaded. 19.The occlusion device of claim 14 wherein the occluding member comprisesa woven mesh.
 20. The occlusion device of claim 19 wherein theself-expanding material and polyester fiber are woven in a ratio of atleast one of 1:1; 1:2; 1:3; 1:4; 2:1; 3:1 and 4:1.